Senior Project Manager (Midwest or West Coast)

Avance Clinical Pty Ltd.

Northern (KY)

Hybrid

USD 110,000 - 170,000

Full time

2 days ago

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Job summary

Avance Clinical Pty Ltd. is seeking a Senior Project Manager to lead clinical trial delivery in the Midwest or West Coast of the US. You will coordinate study teams, manage timelines and budgets, and ensure regulatory compliance across studies.

The role may include line management of project associates and engagement with sponsors and vendors. The Senior PM I will oversee single-site operations or larger multi-region studies, liaise with stakeholders, and drive risk management, trial master file

Qualifications

Bachelor's degree in life sciences, pharmacy, nursing, or equivalent.
3–5 years’ PM experience in a CRO or pharma environment.
PM-related line management experience is desirable.
Experience as a Clinical Research Associate is highly regarded.
Knowledge of ICH GCP and applicable regulatory requirements.

Responsibilities

Autonomously manage all aspects of project delivery from start to finish.
Coordinate internal and external stakeholders to meet timelines.
Maintain sponsor communications to manage timelines, risks and issues.
Prepare Ethics Committee submissions where required.
Develop study plans and documents for Project and Clinical Operations.
Identify and report project risks and deviations.
Review TMF documentation for accuracy and completeness.
Lead clinical operations for single-site studies and monitor plans.
Manage project financial performance including revenue recognition, forecasting and contracts.
Oversee site budgets and clinical trial agreements; review study protocols.
May act as Lead PM on larger or multi-region studies.
Participate in audits and respond to audit findings.
Ensure SAE reporting per protocol requirements.
Mentor junior staff and participate in training.

Skills

PM experience

Budget management

Team leadership

Cross-functional coordination

Education

Bachelor's degree in life sciences/health

Job description

Senior Project Manager (Midwest or West Coast)

We are looking for a Sr. PM to join our team that is located in the Midwest or West Coast Regions of the US.

08th September, 2026

Who are we?
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.
Why should you join Avance Clinical?
We appreciate that our most important asset is our people. We offer a fun, friendlywork environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.
Broad Purpose
Avance Clinicalisa ContractResearchOrganisationwhichoffersspecialised servicessupportingdrug developmentforthe pharmaceutical and biotechnologyindustry.
The Senior Project Manager I (Snr PM I) is responsible for planning and executing clinical trials by coordinating study team members and processes to deliver projects on time, within budget and with the desired outcomes, ensuring the trial is conducted in accordance with the protocol, Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. The Snr PM I may also line manage a team of Project Associates (PA).
CoreResponsibilities

Autonomously manage the performance of all aspects of project delivery from commencement to completion, including:
Coordinate the activities of internal and external stakeholders including the sponsor, third party vendors and site staff to execute projects within agreed timelines.
Maintain effective Sponsor communication to proactively manage project timelines, expectations,risks,and issues.
Prepare or review Ethics Committee submission documents, asrequired.
Develop all study plans and documents to support the effective execution of all Project and Clinical Operations activities.
Identify, evaluate, control, communicate, review and report risks in relation to a project and its critical processes/data.
Ensure protocol deviations areidentified, documented, and reviewed in line with study plans.
Review Trial Master File (TMF) documentation to ensure accuracy and completeness as per SOPs.
For a single-site study, oversee and lead the operations of the clinical team, develop the Clinical MonitoringPlanand review Monitoring Visit Reports.
Effectively manage project financial performance of assigned projects, including revenue recognition, forecasting and contract management, sponsor invoicing, site payment management and tracking, vendor paymentmanagementand tracking.
Review and/or oversee site budget and clinical trialagreementsdevelopment.
Review study protocols and other study related documents.
May act as a Lead PM on larger, more complex studies or those involving more than one region.
Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, andrespond to audit observations, asrequired.
Ensure Serious Adverse Events are reported (initialand follow-up) as per protocol requirements.
Provide guidance and mentoring to less experienced project management staff members andparticipatein training initiatives.
Other duties as directed by Line Management or delegatein line withskills,experienceand/orqualifications.

08th September, 2026

Autonomously manage the performance of all aspects of project delivery from commencement to completion, including:
Coordinate the activities of internal and external stakeholders including the sponsor, third party vendors and site staff to execute projects within agreed timelines.
Maintain effective Sponsor communication to proactively manage project timelines, expectations,risks,and issues.
Prepare or review Ethics Committee submission documents, asrequired.
Develop all study plans and documents to support the effective execution of all Project and Clinical Operations activities.
Identify, evaluate, control, communicate, review and report risks in relation to a project and its critical processes/data.
Ensure protocol deviations areidentified, documented, and reviewed in line with study plans.
Review Trial Master File (TMF) documentation to ensure accuracy and completeness as per SOPs.
For a single-site study, oversee and lead the operations of the clinical team, develop the Clinical MonitoringPlanand review Monitoring Visit Reports.
Effectively manage project financial performance of assigned projects, including revenue recognition, forecasting and contract management, sponsor invoicing, site payment management and tracking, vendor paymentmanagementand tracking.
Review and/or oversee site budget and clinical trialagreementsdevelopment.
Review study protocols and other study related documents.
May act as a Lead PM on larger, more complex studies or those involving more than one region.
Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, andrespond to audit observations, asrequired.
Ensure Serious Adverse Events are reported (initialand follow-up) as per protocol requirements.
Provide guidance and mentoring to less experienced project management staff members andparticipatein training initiatives.
Other duties as directed by Line Management or delegatein line withskills,experienceand/orqualifications.

If applicable to the individual's role, also includes:

Monitor linereports'compliance withuseof expected company systems and processes; training completion and timecard entry, leave entitlement administration; and expense processing.
Actively manage the performance of line reports and individual career development strategies.
Support staff retention initiatives, drive staff recruitment (including interviews and probation period management) and manage staff severance.
Manage PA resource assignments across the department in conjunction with the Project Director team, proactively projecting PA resourceneed.

Departmental Responsibilities

Foster the on-going commitment tomaintaininga healthy team culture and promoting good morale, by activelyparticipatingin regular Project Management Team meetings.
Maintain effective communication with other members of the department.
Proactivelyidentifyrisks related to departmental service provision andassistin their mitigation and resolution.
Manage and track business related expenses as per company policy.
Identifytrainingneeds of the Project Management Team, provide suggestions for, and support delivery ofappropriate trainingactions and programs.
Assistwith the development of departmental SOPs asrequired.
Participate in internal Quality Assurance activities asrequired, including responding to audit findings.

Organisational Responsibilities

Embrace the core values ofAvance Clinicalandendeavortodisplay those attributes at all timeswith clients and staff alike.
Commit toAvance Clinicaltraining programs.
Adhere toAvancequality systems.

All staffare required totake reasonable care for their own health and safety and that of other personnel who may be affected by their conduct.
The accountabilities as specified above may be alteredin accordance withthe changing requirements of the position.
Qualifications,Skills,and Experience

Bachelor's level degree in life sciences, pharmacy,nursing,or equivalent field.
Previousexperience as a PM in a CRO or Pharma company for at least 3-5 years.
Where applicable,previousPM-related line management experience is desirable.
Previousexperience as a Clinical Research Associate (CRA) is highly regarded.
Previoustraining anda workingknowledge of ICH GCP and applicable regulatory requirements.
Clear understanding of the requirement to adhere strictly to client confidentiality.
Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
Demonstrated ability to take initiative in problem solving and in exercising good judgment.
An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.
Ability to work under pressure in a multi-disciplinary team environment.
Willingness to work in, and be supportive of, a positive and dynamic team culture.
Ability to travel (desirable).Veryminimal level of travel may berequired(up to 10%).